Genetic Study of Age Related Hearing Loss (ARHL)

November 21, 2012 updated by: National Taiwan University Hospital

Age-related hearing loss, or presbyacusis, is one of the most common chronically handicapped conditions for the elderly. Many factors including genetics, diet, diseases, drugs, socioeconomic factors and environmental variables were considered to be related to the development of presbyacusis. Evidences have shown that genetic factors play an important role on presbyacusis. However, which genes or their genotypes are associated with presbycusis remain unknown.

The aim of this project was to evaluate the association between the genotype of candidate genes and presbyacusis by cross-section and case-control study. In the first stage, the investigators plan to select 700 healthy subjects older than 50 with symmetric, sensorineural hearing loss. The subjects will receive basic otologic examination, pure tone audiometry, questionnaire, and genotype analysis. Because gender and age would affect hearing loss significantly, The investigators will convert the hearing level of all subjects into a gender and age independent Z-score according to ISO 7029 standard. And, The investigators define subjects within higher 30 % of Z-score as the presbyacusis group, and subjects within lower 30% of Z-score as the control group. Finally, The investigators perform Chi square analysis to test the association between genotype of candidate genes or their combinations in both groups, and calculate the odds ratio for presbyacusis between different genotype of candidate genes. Further more, we will evaluate the effect of genotype of candidate genes, environment factors, and gene-environmental interaction on the severity of presbyacusis by multivariate logistic regression.

In the second stage, The investigators wish to know the pattern of genotype and hearing level in the high risk families, according to results from the first stage, by description and case-control study. The investigators will perform t-test to evaluate the difference of Z-score in both groups. Besides, The investigators try to evaluate the effects of genotypes, environment factors, and gene-environmental interaction on hearing level in high risk families by multivariate logistic regression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwna University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects aged 45 or above, both male and female came to the hospital for health check up

Exclusion Criteria:

  • known ontological disease age under 45 noise exposure history history of ototoxicity psychiatric diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Genetic: genes
Draw blood for genetic screening
Other Names:
  • no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
which gene or Single nucleotide polymorphism is related to age related hearing loss
Time Frame: 2008-2009
2008-2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Which environmental factor(s) or systemic diseases are related to age related hearing loss
Time Frame: 2008-2009
2008-2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Tien-Chen Liu, MD, PhD, Department of Otolayrngology, National Taiwan Univserity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 1, 2008

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 22, 2012

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 21, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200806069R
  • Taiwan NSC 97-2314-B-002-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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